38 results · 106ms · Sources: EU EUDAMED, US FDA

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CROSSTREES PVA POD

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
MEDTRONIC XOMED, INC.·00681490034708·PROSTHESIS 1133372 MOD CUP STAPES

N/A

FDA UDI
MEDTRONIC XOMED, INC.·00763000035297·PROSTHESIS 1133372 MOD CUP STAPES

HHM

FDA UDI
Oticon A/S·05707131261038·H100, MINIRITE 312 WL TC HHM

DreamWear Full

FDA UDI
Respironics, Inc.·00606959046337·DreamWear Full Face Mask, Large Cushion, Small ...

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613025205·Mayo-Harrington Scissors, Super Cut, Curved, Bl...

NUVANT, MOBILC CARDIAC TELEMETRY

FDA 510(k)
FDA Class 2 ·Cardiovascular

SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS

FDA 510(k)
FDA Class 2 ·Neurology

KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LOX·March 17, 2020

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

UNKNOWN

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 20, 2011

IKAZUCHI ZERO

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LOX·June 13, 2019

KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LOX·August 19, 2019

Philips Respironics DreamWear Full Face Mask

FDA Enforcement
Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

IKAZUCHI ZERO

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LOX·August 20, 2019

KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LOX·August 21, 2019

KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code LOX·April 14, 2022

KANEKA PTCA CATHETER CO-R8 (TASUKI)

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LOX·December 13, 2020

KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code LOX·December 21, 2020